We will investigate the effect of Olmesartan Medoxomil 40 mg on the reendothelialization capacity of Endothelial Progenitor Cells in patients with chronic kidney disease. In this clinical setting Olmesartan Medoxomil is expected to have tissue protective effeects.
Conditions
Interventions
Trade Name: Olmetec 40mg Filmtablette
Product Name: Olmetec
Pharmaceutical Form: Tablet
INN or Proposed INN: Olmesartan
CAS Number: 0144689-63-4
Concentration unit: mg milligram(s)
Concentration type
Sponsors
University of the Saarland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * Signed written informed consent * Woman or man aged 18 to 70 years * Chronic Kidney Disease (CKD II-IV) * Endogenous creatinine clearance between 15 ml/min and 90 ml/min. No impending need for dialysis during the study * HbA1C =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: * Myelodysplastic or –proliferative diseases * Malignant disease diagnosed within the last 5 years * Renal anemia (Hb =10,5 g/dl for men or =10 g/dl for women) or therapy with rHuEPO or analogs * Therapy with growth factors, e.g. GM-CSF or VEGF * Statin Therapy * Bleeding episodes relevant for Hb within the last 3 months or known gastrointestinal bleeding sources * Foreseeable need for dialysis * Sitting dBP >100 mmHg with standard antihypertensives (incl. ACE Inhibitors or ARB) * Sitting sBP >100 mmHg with standard antihypertensives (incl. ACE Inhibitors or ARB) * Known intolerance of ARBs, e.g. Olmetec®, Diovan®, Lorzaar®, Atacand®, Aprovel®, Mircardis®, Teveten® * Known HIV infection * Systemic chemotherapy or radiotherapy * Chronic infection and/or CRP >10 mg/l at the beginning of the study * Acute cardiovascular episodes * Organ transplants * Pregnant or lactating woman * Woman of childbearing potential without adequate contraception * Psychiatric disease or chronic cerebral attacks * Non-compliance or participation in another clinical study within the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the effects of Olmesartan Medoxomil 40 mg on the re-endothelialization capacity of Endothelial Progenitor Cells in patients with chronic kidney disease;Secondary Objective: to assess the effects of Olmesartan Medoxomil 40 mg on endothelial function, number and function of Endothelial Progenitor Cells and their production of superoxides as well as the bioavailabiliy of nitric oxide to assess safety and tolerability of Olmesartan Medoxomil 40 mg in patients with chronic kidney disease. ;Primary end point(s): The primary study end point is the re-endothelialized area after experimental carotid injury in a nude mice model. | — |
Countries
Germany
Outcome results
None listed